MitoQ for Cold Exposure

Overseen By Billie Alba, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: United States Army Research Institute of Environmental Medicine

Must not be taking: Antihypertensives, Statins

Disqualifiers: Cold injuries, Raynaud's, Asthma, others

Compensation: Varies

Number of Visits: Unknown

Duration: 2.5 hours per session

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications or dietary supplements that could affect your heart, blood flow, or body temperature control, except for birth control.

What data supports the effectiveness of the drug MitoQ for cold exposure?

Research shows that MitoQ, a mitochondria-targeted antioxidant, can protect kidney cells from damage during cold storage by reducing harmful oxidants and improving cell survival. This suggests it might help protect cells from cold-related stress in other situations as well. ^{1 2 3 4 5}

How does the drug MitoQ differ from other treatments for cold exposure?

MitoQ is unique because it is a mitochondria-targeted antioxidant that specifically reduces oxidative stress within cells, which can help protect against damage caused by cold exposure. Unlike other treatments, MitoQ accumulates inside mitochondria, enhancing its effectiveness in preventing cell damage and improving cell viability. ^{1 2 3 4 6}

What is the purpose of this trial?

Individuals who operate in cold weather are at risk of developing cold injuries, for example, frostbite. They also often experience a loss of hand function and joint mobility due to a decrease in skin temperature and blood flow. In addition, the risk of getting a cold injury is higher in the Black population compared to other racial and ethnic groups. Increases in oxidant compounds can cause the blood vessels in the skin to narrow and decrease skin temperature in the cold. However, it is unknown whether the higher risk of cold injury in Black individuals is because of a greater amount of oxidant compounds in the blood vessels. The purpose of this research is to see if an antioxidant supplement called MitoQ can help to improve skin temperature and blood flow in the cold and if the improvement is greater in Black individuals.

Eligibility Criteria

This trial is for people who work in cold environments and are at risk of cold injuries like frostbite. It's particularly focused on understanding if Black individuals, who have a higher risk of such injuries, can benefit from an antioxidant supplement called MitoQ to improve skin temperature and blood flow.

Inclusion Criteria

I have regular menstrual cycles or use birth control pills or devices.

Have supervisor approval if active-duty military or a federal employee at NSSC

In good health as determined by OMSO (Office of Medical Support and Oversight)

Exclusion Criteria

Known allergy to MitoQ

Difficulty swallowing pills

I have a condition affecting my heart, lungs, kidneys, muscles, or nerves.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cold exposures following ingestion of MitoQ or placebo, including hand immersion in cold water and exposure to cold air.

2.5 hours per session

Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measurements of skin blood flow, temperature, and other physiological parameters.

4 weeks

Treatment Details

Interventions

• Mitoquinone mesylate (MitoQ)

Trial Overview The study tests the effects of MitoQ supplementation versus a placebo on skin blood flow and temperature during exposure to cold conditions. Participants will immerse their hands in cold water or be exposed to cold air to simulate real-world conditions.

Participant Groups

Group I: MitoQ - Cold Water Hand Immersion Experimental Treatment 2 Interventions

Four 20 mg MitoQ capsules (80 mg total) are taken \~1 hour before a 30-minute hand immersion in 54°F water.

Group II: MitoQ - Cold Air Exposure Experimental Treatment 2 Interventions

Four 20 mg MitoQ capsules (80 mg total) are taken \~1 hour before a 90-minute cold exposure in 41°F air.

Group III: Placebo - Cold Water Hand Immersion Placebo Group 2 Interventions

Four placebo (microcrystalline cellulose) capsules are taken \~1 hour before a 30-minute hand immersion in 54°F water.

Group IV: Placebo - Cold Air Exposure Placebo Group 2 Interventions

Four placebo (microcrystalline cellulose) capsules are taken \~1 hour before a 90-minute cold exposure in 41°F air.

Who Is Running the Clinical Trial?

United States Army Research Institute of Environmental Medicine

Lead Sponsor

Trials

67

Recruited

3,700+

Findings from Research

Mitoquinone (MitoQ), when added to University of Wisconsin preservation solution, significantly reduced oxidative damage and improved cell viability in kidneys subjected to cold storage, suggesting it could protect against tissue injury during organ preservation.

In a study involving isolated rat kidneys, MitoQ treatment completely prevented mitochondrial dysfunction and significantly improved renal morphology, indicating its potential to reduce kidney discardment and enhance renal function post-transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The mitochondria-targeted antioxidant mitoquinone protects against cold storage injury of renal tubular cells and rat kidneys. Mitchell, T., Rotaru, D., Saba, H., et al.[2021]

A sensitive and accurate liquid chromatography/tandem mass spectrometry (LC/MS/MS) assay was developed to measure mitoquinone levels and its metabolites in rat plasma, demonstrating a linear calibration curve and a low limit of quantitation (0.5 ng/mL).

The pharmacokinetic study identified four metabolites of MitoQ10 in rat plasma, suggesting that MitoQ10 is effectively processed in the body, which is important for understanding its potential therapeutic effects in neurodegenerative diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitation and metabolism of mitoquinone, a mitochondria-targeted antioxidant, in rat by liquid chromatography/tandem mass spectrometry. Li, Y., Zhang, H., Fawcett, JP., et al.[2018]

MitoQ, a coenzyme Q10 derivative, significantly improves the post-thaw viability and functionality of cryopreserved buffalo skin fibroblasts, particularly at lower concentrations (0.1-0.5 μM), by reducing reactive oxygen species (ROS) and enhancing mitochondrial membrane potential (MMP).

Higher concentrations of MitoQ (2-10 μM) were found to be detrimental, increasing oxidative damage, highlighting the importance of dose management in using MitoQ for cell recovery after cryopreservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitochondria-targeted antioxidant MitoQ ameliorates ROS production and improves cell viability in cryopreserved buffalo fibroblasts. Punetha, M., Saini, S., Chaudhary, S., et al.[2023]

MitoQ, a targeted antioxidant, effectively reduces oxidative DNA damage in T lymphocytes from older adults when exposed to oxidative stress, indicating its potential to improve immune function with age.

Higher concentrations of mitoQ (0.5 and 1.0 μM) significantly decreased endogenous DNA damage, suggesting that it may help combat age-related decline in immune cell function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An investigation of the effects of MitoQ on human peripheral mononuclear cells. Marthandan, S., Murphy, MP., Billett, E., et al.[2021]

Mitoquinone (MitoQ(10)) is effectively absorbed in the intestines, with 18-41% of the administered dose accumulating intracellularly, indicating its potential as a treatment for neurodegenerative diseases.

The absorption of MitoQ(10) can be significantly enhanced by the presence of serum proteins like bovine serum albumin, suggesting that its bioavailability may improve in real-life conditions despite some limitations from metabolism and transport proteins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transport and metabolism of MitoQ10, a mitochondria-targeted antioxidant, in Caco-2 cell monolayers. Li, Y., Fawcett, JP., Zhang, H., et al.[2018]

MitoQ effectively reduces gentamicin-induced apoptosis in HEI-OC1 cells, indicating its potential to protect against hearing loss caused by aminoglycoside antibiotics.

Importantly, MitoQ does not compromise the antimicrobial efficacy of gentamicin, suggesting it could be a safe adjunct treatment to prevent ototoxicity while maintaining antibiotic effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of gentamicin-induced apoptosis with the mitochondria-targeted antioxidant mitoquinone. Ojano-Dirain, CP., Antonelli, PJ.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

The mitochondria-targeted antioxidant mitoquinone protects against cold storage injury of renal tubular cells and rat kidneys. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Quantitation and metabolism of mitoquinone, a mitochondria-targeted antioxidant, in rat by liquid chromatography/tandem mass spectrometry. [2018]

3. Scotland pubmed.ncbi.nlm.nih.gov

Mitochondria-targeted antioxidant MitoQ ameliorates ROS production and improves cell viability in cryopreserved buffalo fibroblasts. [2023]

4. England pubmed.ncbi.nlm.nih.gov

An investigation of the effects of MitoQ on human peripheral mononuclear cells. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Transport and metabolism of MitoQ10, a mitochondria-targeted antioxidant, in Caco-2 cell monolayers. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Prevention of gentamicin-induced apoptosis with the mitochondria-targeted antioxidant mitoquinone. [2018]